Identifiers
- 510(k) Number
- K181249 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EUSRA RF Electrode is a radiofrequency (RF) electrode designed for use in general and plastic surgery procedures. It delivers controlled thermal energy to tissue, facilitating procedures such as skin tightening, fat reduction, and collagen remodeling through precise RF ablation.
This device is supplied sterile and intended for single-use. It is classified under the product code GEI and has received FDA 510(k) clearance, MDD, and MDR authorizations. The electrode is intended for use in clinical settings and must be handled according to standard aseptic techniques. No MRI safety information is specified.
Frequently asked questions
What types of surgical procedures is the EUSRA RF Electrode intended to assist with, and how does it work?
The EUSRA RF Electrode is designed for use in general and plastic surgery procedures, specifically for controlled tissue modification. It delivers radiofrequency (RF) energy to target tissues, enabling procedures like skin tightening, fat reduction, and collagen remodeling through precise thermal ablation. The device achieves this by heating tissue in a controlled manner, promoting remodeling without invasive incisions.
Is the EUSRA RF Electrode intended for reuse, or is it meant to be used only once?
The EUSRA RF Electrode is explicitly supplied sterile and intended for single-use only. This design ensures patient safety and hygiene, as reuse could compromise sterility and increase infection risks. Always follow standard aseptic techniques when handling the device.
What regulatory pathways has the EUSRA RF Electrode undergone, and what does that mean for its use?
The EUSRA RF Electrode has received FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. This means it has been evaluated for safety and performance against established standards and is legally permitted for use in markets requiring these certifications. The GEI product code indicates it falls under general and plastic surgery classifications.
How should the EUSRA RF Electrode be stored, and are there any special handling instructions?
Since the EUSRA RF Electrode is sterile and single-use, it should be stored in its original packaging until ready for use. Ensure the packaging remains intact and unopened to maintain sterility. Store in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for handling to prevent contamination.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181249 | Class II | Active |
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Manufacturer
- Manufacturer
- Starmed Co., Ltd
- FDA Applicant
- Starmed Co., Ltd.
Sources (2)
- FDA 510(k) K181249 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026